Quality Specialist

East Bay, (none selected) | Direct Hire

Post Date: 09/14/2016 Job ID: 1088 Industry: Consumer Electronics

Summary of Responsibilities:

To ensure compliance to all quality standards through support of the company quality management system, that affects the design, development and production of Neodyne products.

Essential Functions:

1. Maintain current knowledge of regulatory requirements for Quality Assurance (e.g. FDA Quality System Regulation, ISO 13485).

2. Maintain and perform complaint handling and post market surveillance. Perform failure analysis investigations to support complaint investigations, this include performing failure investigations and documenting complaint investigations. Monitor and perform monthly complaint trends and report to management.

3. Perform inspection/testing and prepare quality inspection records to maintain quality levels at: o In-Process / Final Inspection (as required) o Receiving inspection (as required) o Lot Release Testing (as required) o Perform lot history record reviews for completeness.

4. Coordinate and participate in quarterly Quality Metrics presentations and Management Review presentations

5. Coordinate and approve non-conforming material report (NCMR) activities required to maintain compliance to NCMR procedures from initiation through closure.

6. Support the compliance of the Corrective and Preventive Action and Supplier Corrective Action system including the timeliness of processing CAPA’s and SCAR’s. Maintenance of all CAPA and SCAR files, coordinating efforts with the owners and managers; ensuring compliance with applicable regulations.

7. Maintain the Approved Vendor List, maintain vendor files with updated certifications, and complete vendor re-evaluations

8. Perform activities related to the Document Control function.

9. Coordinate and perform activities to ensure that all calibration and maintenance is completed for tools and instruments as needed. Maintain the Preventive Maintenance and Calibration files and database.

10. Notify personnel of training requirements and enter training data into the training tracker. Run training compliance reports, follow up with personnel and escalate as appropriate to ensure timely training. Coordinate and support activities to maintain a compliant in-house training program.

11. Establish and maintain external Standards document system.

12. Support Internal Audit Process including, compliance to Internal Audit schedule, and the monitoring of timely closure of findings.

13. Complete projects in an aggressive manner consistent with corporate objectives. Take an active role in determining day-to-day tasks.

14. Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/MDD regulations.

15. Maintain a professional, credible image with suppliers, co-workers, consultants, and other stakeholders that influence product development and acceptance.

16. Willingness to travel to vendor sites as required.

17. Maintain knowledge of current methods and techniques used in manufacturing.

2. Required Experience

? A minimum of 1-3 years of related experience, preferably in a medical device company.

3. Essential Skills and Abilities

? Proficiency with PC-based office computers, including familiarity with Microsoft Word, Excel, PowerPoint, and Outlook required.

? Ability to work independently, using good judgment, initiative and analytical abilities.

? Ability to work as a team member and ability to be very flexible, adaptable, and to work under pressure.

? Requires above average reading, verbal and written communications and presentation skills.

? Must be a friendly, helpful person who enjoys contact with employees and external contacts at all levels; must have the ability to engage people in conversations; and good listening skills.

? Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while staying flexible to shift tasks frequently.

? Excellent interpersonal and negotiating skills; ability to adapt to changing work priorities; and ability to maintain good working relationships while dealing appropriately with sensitive and confidential matters and with a wide variety of personal and telephone contacts.

? Regular and punctual attendance and dependability in meeting commitments and deadlines are essential functions of this position.

? Proficiency in business English and grammar; good arithmetic skills and attention to detail to maintain records and process reports.

? Must be available and willing to work flexible schedules, as needed.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities.

Other Responsibilities

1. Perform other duties as assigned.


1. Education and Training

? High School diploma required. AA and experience in the medical device industry is preferred, or equivalent combination of training and experience.

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